HIV, Buprenorphine, and the Criminal Justice System

Not Applicable

Completed

• Conditions: Opiate Addiction; Human Immunodeficiency Virus; Acquired Immunodeficiency Syndrome; Drug Dependence
• Interventions: Drug: Buprenorphine/naloxone; Drug: Placebo Oral Tablet

• Registration Number: NCT01550341
• Lead Sponsor: Yale University

Brief Summary

The aims of STRIDE were changed as of July, 2014. The revised project, called STRIDE2, has a longitudinal, non-randomized, observational study design. The population under study consists of individuals living with HIV who are dependent on opioids.

Detailed Description

Presented in the results section are the summary of outcomes from the STRIDE RCT that were collected prior to the change in study design. The STRIDE study became STRIDE2 (NCT03583138). Those individuals originally enrolled in the STRIDE RCT will be followed for 12 months.

STRIDE2 will assist in identifying and monitoring individuals' HIV risk behaviors and provide resources to seek treatment for their HIV care and substance use. The goal of STRIDE2 is to examine if there are differences in HIV, drug use, and other outcomes between individuals receiving treatment versus individuals actively using, not actively using and not in treatment, and individuals on Methadone, Suboxone, or in some other treatment.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-06-21
• Study Start: 2012-02-23
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-12
• Primary Completion: 2015-11-30
• Study Completion: 2016-11-30
• Results First Submitted: 2017-08-17
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-27
• Last Update Submitted: 2020-04-27
• Results First Posted: 2020-05-06
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• HIV+
• Age ≥18 yrs
• Meets DSM-IV criteria for opioid dependence
• Has medical entitlements in DC
• Able to provide informed consent
• Able to communicate in English or Spanish

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Exclusion Criteria

• Being prescribed an opiate medication for a chronic pain condition or expressing the need to be placed on chronic pain medical conditions for a documented pain condition
• Currently receiving methadone dosing of over 30 mg per day and uninterested in changing to buprenorphine
• AST and ALT >5x the upper limit of normal (AST≥175, ALT≥195)
• Pregnant or unwilling to use contraception (including OCPs, patch, Depo-Provera, condoms, etc.)
• Breastfeeding or unwilling to stop breastfeeding
• Subject is part of another pharmacological research study
• Liver dysfunction (acute hepatitis, liver failure or hepatic dysfunction)
• Suicidal ideation
• Hypersensitivity to buprenorphine

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buprenorphine	Buprenorphine/naloxone	-
Placebo	Placebo Oral Tablet	-

Primary Outcome Measures

Name	Time	Method
CD4 Count Absolute	12 Months	CD4 Count
Viral Load	12 Months	Viral Load
Log Viral Load	12 Months	Log Viral Load
CD4 Percent	12 Months	CD4 Percent

Secondary Outcome Measures

Name	Time	Method
Improved Criminal Justice Outcomes	baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52	Measure change in time to reincarceration,number of days reincarcerated, and crime days, between baseline and each monthly follow-up visit.
Improved Opioid Treatment Outcomes	baseline, 3 months, 9 months, 12 months	Monitor relapse to opioid use, retention on Buprenorphine or placebo, percent days using opioids, lower addiction severity, lower craving, between baseline and subsequent follow-up visits. Monitor urine toxicology screens on every visit for approximately one year.

Trial Locations

Locations (1)

Howard University; 🇺🇸 Washington, District of Columbia, United States